Insulin Requirement for Pure-protein Meal in Children With Type 1 Diabetes on Insulin Pumps.

M

Medical University of Warsaw

Status and phase

Unknown
Phase 4

Conditions

Diabetes type1

Treatments

Drug: Insulin aspart
Drug: Insulin glulisine
Drug: Insulin lispro

Study type

Interventional

Funder types

Other

Identifiers

NCT02685449
Białko_5h

Details and patient eligibility

About

This is a randomized, cross-over study. The aim of this study is to compare the post-prandial glycaemic variability after pure protein meal following with an administration of square-wave bolus of meal-insulin or without any meal-insulin bolus on the other day. Prolonged post-prandial glycaemic variability will be identified using the self-monitoring of blood glucose (10-point curve) and CGMS.

Full description

The square-wave bolus (for meals rich in fat and/or protein) is evenly delivered over several hours as programmed by the patient. The required insulin dose will be calculated based on patient's insulin-exchange ratio. Pure protein meal will be given 3 hours after a first breakfast. To provide the minimal impact of the previous breakfast, all patients will receive up to 120 kcal of carbohydrates and <100 kcal from protein and fat for the first breakfast (without any extended bolus) Patients receive a standardized pure protein meal at a second breakfast time. Meal insulin will be given as a square bolus or no meal -insulin will be given at all. The 5h post-meal glucose excursions will be recorded by self-blood glucose measurements (SMBG) (every 30 minutes) and continuous glucose monitoring system (CGMS). The intervention is taking part under in-patient clinical conditions.

Enrollment

70 estimated patients

Sex

All

Ages

10 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • duration of type 1 diabetes longer than 12 months
  • insulin pump therapy longer than 3 months
  • written informed consent by patients and parents
  • insulin requirement more than 0,5 units/kg/day

Exclusion criteria

  • diabetes related complications (e.g. nephropathy)
  • chronic kidney diseases
  • any disease judged by the investigator to affect the trial
  • withdrawal of consent to participate in the study

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

70 participants in 2 patient groups, including a placebo group

group A
Placebo Comparator group
Description:
On the first study day, insulin bolus was not given before a standardized pure protein meal. On the second day, pre-breakfast insulin was given as a square-wave bolus before the same standardized pure protein meal. The fat-protein-insulin ratio on both study days were identical to the patient's ratio when entering trial. Kind of study bolus insulin will be a rapid-acting insulin analog same as previously used by the participant (before entering the trial) - insulin aspart, insulin lispro or insulin glulisine
Treatment:
Drug: Insulin lispro
Drug: Insulin glulisine
Drug: Insulin aspart
group B
Active Comparator group
Description:
On the first study day, pre-breakfast insulin was given as a square-wave bolus before a standardized pure protein meal. On the second day, insulin bolus was not given before the same standardized pure protein meal. The fat-protein-insulin ratio on both study days were identical to the patient's ratio when entering trial. Kind of study bolus insulin will be a rapid-acting insulin analog same as previously used by the participant (before entering the trial) - insulin aspart, insulin lispro or insulin glulisine
Treatment:
Drug: Insulin lispro
Drug: Insulin glulisine
Drug: Insulin aspart

Trial contacts and locations

1

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Central trial contact

Kamila Indulska; Katarzyna Dżygało

Data sourced from clinicaltrials.gov

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